Recruiting
Phase 3

Upadacitinib

Sponsor:

AbbVie

Code:

NCT06012240

Conditions

Alopecia Areata

Eligibility Criteria

Sex: All

Age: 12 - 63

Healthy Volunteers: Not accepted

Interventions

Upadacitinib

Placebo

Study Details

Brief summary:

Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.

Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide.

Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions

Alopecia Areata

Study ID

NCT06012240

Start date

Oct 11, 2023

Status verified date

Jul, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 63

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult individuals must be < 64 years old at Baseline Visit. Where permitted outside United States (US)/European Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.
  • Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score >= 50 scalp hair loss at Screening and Baseline.
  • Severe AA with no spontaneous scalp hair regrowth over the past 6 months.
  • Current episode of AA of less than 8 years.

Exclusion Criteria:

  • Current diagnosis of primarily diffuse type of AA.
  • Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.
  • Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study 1: Group 1 Upadacitinib Dose A

Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.

experimental: Study 1: Group 2 Upadacitinib Dose B

Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.

experimental: Study 1: Group 3 Placebo

Participants will receive matching placebo once daily for 24 weeks in Period A.

experimental: Study 1: Group 4 Upadacitinib Dose A

Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.

experimental: Study 1: Group 5 Upadacitinib Dose B

Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.

experimental: Study 1: Group 6 Placebo

Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.

experimental: Study 2: Group 1 Upadacitinib Dose A

Participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.

experimental: Study 2: Group 2 Upadacitinib Dose B

Participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.

experimental: Study 2: Group 3 Placebo

Participants will receive matching placebo once daily for 24 weeks in Period A.

experimental: Study 2: Group 4 Upadacitinib Dose A

Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.

experimental: Study 2: Group 5 Upadacitinib Dose B

Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.

experimental: Study 2: Group 6 Placebo

Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.

experimental: Study 3: Group 1 Upadacitinib Dose B (SALT > 20)

Participants receiving upadacitinib Dose A with a SALT score > 20 at Week 52 (end of Period B) of Study 1 or Study 2 will dose escalate to upadacitinib Dose B once daily for 108 weeks.

experimental: Study 3: Group 2 Upadacitinib Dose A (SALT ≤ 20)

Participants receiving upadacitinib Dose A with a SALT score ≤ 20 at Week 52 (end of Period B) of Study 1 or Study 2 will remain on upadacitinib Dose A once daily for 108 weeks.

experimental: Study 3: Group 3 Upadacitinib Dose B (Non-Sustained)

Participants who end Period B on upadacitinib Dose B with a with a SALT score > 20 at Week 40 or Week 52 of Study 1 or Study 2 will remain on upadacitinib Dose B once daily for 108 weeks.

experimental: Study 3: Group 4 Upadacitinib Dose B (Sustained)

Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose B once daily for 108 weeks.

experimental: Study 3: Group 5 Upadacitinib Dose A (Sustained)

Participants who end Period B on upadacitinib Dose B with a with a SALT score ≤ 20 at Week 40 and Week 52 of Study 1 or Study 2 will be re-randomized to receive upadacitinib Dose A once daily for 108 weeks.

experimental: Study 4: Group 1 Upadacitinib Dose A

US only adolescent participants will receive upadacitinib Dose A once daily for 52 weeks in Period A and Period B.

experimental: Study 4: Group 2 Upadacitinib Dose B

US only adolescent participants will receive upadacitinib Dose B once daily for 52 weeks in Period A and Period B.

experimental: Study 4: Group 3 Placebo

US only adolescent participants will receive matching placebo once daily for 24 weeks in Period A.

experimental: Study 4: Group 4 Upadacitinib Dose A

Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose A once daily for 28 weeks in Period B.

experimental: Study 4: Group 5 Upadacitinib Dose B

Participants initially randomized to placebo (Period A) with a SALT score > 20 at Week 24 will be re-randomized to receive upadacitinib Dose B once daily for 28 weeks in Period B.

experimental: Study 4: Group 6 Placebo

Participants initially randomized to placebo with a SALT score ≤ 20 at Week 24 will continue on placebo through Week 160.

Interventions

Upadacitinib

Oral Tablets

Placebo

Oral Tablets

Primary outcome measure

  • Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20 [ Time Frame: Week 24 ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 164 weeks ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

First Oc Dermatology /ID# 259220

Recruiting

Fountain Valley, California, United States, 92708

Dermatology Research Associates /ID# 258033

Recruiting

Los Angeles, California, United States, 90045

Integrative Skin Science and Research /ID# 258114

Recruiting

Sacramento, California, United States, 95815

University of California Davis Health /ID# 258112

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Coordinator

916-551-2635

Clinical Trials Research Institute /ID# 258021

Recruiting

Thousand Oaks, California, United States, 91320-2130

Skin Care Research Boca Raton /ID# 258012

Recruiting

Boca Raton, Florida, United States, 33486-2269

Contacts

Site Coordinator

+1-561-948-3116

Skin Care Research - Hollywood /ID# 259210

Recruiting

Hollywood, Florida, United States, 33021-6748

Contacts

Site Coordinator

+1-561-948-3116

GSI Clinical Research, LLC /ID# 259352

Recruiting

Margate, Florida, United States, 33063

Lenus Research and Medical Group /ID# 259356

Recruiting

Miami, Florida, United States, 33172

Advanced Clinical Research Institute - Tampa /ID# 259204

Recruiting

Tampa, Florida, United States, 33607

Contacts

Site Coordinator

1-813-362-1037

Indiana University Health University Hospital /ID# 259827

Recruiting

Indianapolis, Indiana, United States, 46202

Tulane University School of Medicine /ID# 259799

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Site Coordinator

504-988-5135

Derm Institute of West Michigan /ID# 259546

Recruiting

Caledonia, Michigan, United States, 49316-7478

Contacts

Site Coordinator

616-512-4445

Clarkston Dermatology /ID# 258018

Recruiting

Clarkston, Michigan, United States, 48346

Skin Specialists /ID# 259237

Recruiting

Omaha, Nebraska, United States, 68144

Contacts

Site Coordinator

402-697-6599

Las Vegas Dermatology /ID# 279317

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Site Coordinator

702 456 3120

Skin Cancer and Dermatology Institute - Reno /ID# 259208

Recruiting

Reno, Nevada, United States, 89509

Contacts

Site Coordinator

775-336-3665

Equity Medical /ID# 266680

Recruiting

New York, New York, United States, 10023-7340

Sadick Research Group LLC /ID# 266790

Recruiting

New York, New York, United States, 10075

Cleveland Clinic - Cleveland /ID# 258113

Recruiting

Cleveland, Ohio, United States, 44195

Dermatologists of Southwest Ohio, Inc /ID# 260116

Recruiting

Mason, Ohio, United States, 45040-4520

Contacts

Site Coordinator

513-701-5526

Oregon Dermatology and Research Center /ID# 258243

Recruiting

Portland, Oregon, United States, 97210

Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 278359

Recruiting

Spartanburg, South Carolina, United States, 29307

Contacts

Site Coordinator

864 574-0017 ext 8

International Clinical Research - Tennessee LLC /ID# 259552

Recruiting

Murfreesboro, Tennessee, United States, 37130-2450

Arlington Research Center, Inc /ID# 258028

Recruiting

Arlington, Texas, United States, 76011

Bellaire Dermatology Associates /ID# 259360

Recruiting

Bellaire, Texas, United States, 77401

U.S. Dermatology Partners - Cedar Park /ID# 259367

Recruiting

Cedar Park, Texas, United States, 78613

Contacts

Site Coordinator

512-260-5860

Dermatology Treatment and Research Center /ID# 259357

Recruiting

Dallas, Texas, United States, 75230

Dermatology Specialists of Spokane /ID# 278362

Recruiting

Spokane, Washington, United States, 99202

West Virginia University Hospitals /ID# 278707

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

AbbVie

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Alopecia Areata
  • Upadacitinib
  • Rinvoq
  • ABT-494

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-03.